Cast Immobilization for Non-Displaced Scaphoid Fractures

NCT ID: NCT00916539

Last Updated: 2017-04-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This trial is trying to understand if immobilization of the thumb after a non-displaced scaphoid fracture affects recovery. The standard of care overseas is a cast that allows for free movement of the thumb, and in the United States it is a cast that immobilizes the thumb. This study is attempting to understand if there is a difference.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-displaced Scaphoid Fractures

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cast that immobilizes the thumb

Cast that immobilizes the thumb

Group Type EXPERIMENTAL

Cast that immobilizes the thumb

Intervention Type DEVICE

Cast that immobilizes the thumb

Cast that does not immobilize the thumb

Cast that does not immobilize the thumb

Group Type ACTIVE_COMPARATOR

Cast that does not immobilize the thumb

Intervention Type DEVICE

Cast that does not immobilize the thumb

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cast that immobilizes the thumb

Cast that immobilizes the thumb

Intervention Type DEVICE

Cast that does not immobilize the thumb

Cast that does not immobilize the thumb

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 18 years or older
2. Isolated fracture of the scaphoid
3. No displacement of the scaphoid fracture on CT scan

Exclusion Criteria

1. Associated ipsilateral ligament injury or fracture
2. Pregnant Patient
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

David C. Ring, MD

Principal Investigator; Director of Research, Hand Service

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David C Ring, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Massachusettes General Hospital

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB 2006p001424

Identifier Type: -

Identifier Source: secondary_id

2006P-001424

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mallet Finger Splinting Study
NCT01388751 COMPLETED NA